Newsletters

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.

Updated 26/06/2025:
Section 'Clinical Trials Information System (CTIS) newsflash'

Also on this topic

• Newsletter archive

Human medicines highlights

Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all EMA's activities in the area of human medicines.

Issues from May 2024 (Issue 180) onwards are available at the link below:

• Human Medicines Highlights: Issue 180 onwards

Use this link to receive Human Medicines Highlights by email:

• Subscribe to Human Medicines Highlights 

Select the expandable panel below to access previous issues:

Human medicines highlights - Issue 118-179

Human medicines highlights - April 2024

Reference Number: Issue 179

Human medicines highlights - March 2024

Reference Number: Issue 178

Human medicines highlights - February 2024

Reference Number: Issue 177

Human medicines highlights - January 2024

Reference Number: Issue 176

Human medicines highlights - November-December 2023

Reference Number: Issue 175

Human medicines highlights - October 2023

Reference Number: Issue 174

Human medicines highlights - September 2023

Reference Number: Issue 173

Human medicines highlights - August 2023

Reference Number: Issue 172

Human medicines highlights - July 2023

Reference Number: Issue 171

Human medicines highlights - June 2023

Reference Number: Issue 170

Human medicines highlights - May 2023

Reference Number: Issue 169

Human medicines highlights - April 2023

Reference Number: Issue 168

Human medicines highlights - March 2023

Reference Number: Issue 167

Human medicines highlights - February 2023

Reference Number: Issue 166

Human medicines highlights - January 2023

Reference Number: Issue 165

Human medicines highlights - December 2022

Reference Number: Issue 164

Human medicines highlights - November 2022

Reference Number: Issue 163

Human medicines highlights - September 2022

Reference Number: Issue 162

Human medicines highlights - August 2022

Reference Number: Issue 161

Human medicines highlights - July 2022

Reference Number: Isssue 160

Human medicines highlights - June 2022

Reference Number: Isssue 159

Human medicines highlights - April 2022

Reference Number: Isssue 157

Human medicines highlights - March 2022

Reference Number: Issue 156

Human medicines highlights - February 2022

Reference Number: Issue 155

Human medicines highlights - January 2022

Reference Number: Issue 154

Human medicines highlights - December 2021

Reference Number: Issue 153

Human medicines highlights - November 2021

Reference Number: Issue 152Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Human medicines highlights - October 2021

Reference Number: Issue 151

Human medicines highlights - September 2021

Reference Number: Issue 150

Human medicines highlights - August 2021

Reference Number: Issue 149

Human medicines highlights - July 2021

Reference Number: Issue 148

Human medicines highlights - June 2021

Reference Number: Issue 147

Human medicines highlights - May 2021

Reference Number: Issue 146

Human medicines highlights - April 2021

Reference Number: Issue 145

Human medicines highlights - March 2021

Reference Number: Issue 144

Human medicines highlights - February 2021

Reference Number: Issue 143

Human medicines highlights - January 2021

Reference Number: Issue 142Summary:

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Human medicines highlights - December 2020

Reference Number: Issue 141

Human medicines highlights - November 2020

Reference Number: Issue 140

Human medicines highlights - October 2020

Reference Number: Issue 139

Human medicines highlights - September 2020

Reference Number: Issue 138

Human medicines highlights - August 2020

Reference Number: Issue 137

Human medicines highlights - July 2020

Reference Number: Issue 136

Human medicines highlights - June 2020

Reference Number: Issue 135

Human medicines highlights - May 2020

Reference Number: Issue 134

Human medicines highlights - April 2020

Reference Number: Issue 133

Human medicines highlights - March 2020

Reference Number: Issue 132

Human medicines highlights - February 2020

Reference Number: Issue 131

Human medicines highlights - January 2020

Reference Number: Issue 130

Human medicines highlights - December 2019

Reference Number: Issue 129

Human medicines highlights - November 2019

Reference Number: Issue 128

Human medicines highlights - October 2019

Reference Number: Issue 127

Human medicines highlights - September 2019

Reference Number: Issue 126

Human medicines highlights - August 2019

Reference Number: Issue 125

Human medicines highlights - July 2019

Reference Number: Issue 124

Human medicines highlights - June 2019

Reference Number: Issue 123

Human medicines highlights - May 2019

Reference Number: Issue 122

Human medicines highlights - April 2019

Reference Number: Issue 121

Human medicines highlights - March 2019

Reference Number: Issue 120

Human medicines highlights - February 2019

Reference Number: Issue 119

Human medicines highlights - January 2019

Reference Number: Issue 118

EU Regulatory Oncology Newsletter

Issues from October 2024 onwards are available at the link below: 

• EU Regulatory Oncology Newsletter

Use this link to receive the EU Regulatory Oncology Newsletter by email:

• Subscribe to EU Regulatory Oncology Newsletter

Small and Medium-sized Enterprises (SMEs) Highlights

Issues from February 2024 (Issue 61) onwards are available at the link below: 

• Small and Medium-sized Enterprises (SMEs) Highlights: Issue 61 onwards

Use this link to receive Small and Medium-sized Enterprises (SMEs) Highlights by email:

• Subscribe to Small and Medium-sized Enterprises (SMEs) Highlights

Select the expandable panel below to access previous issues:

Small and Medium-sized Enterprises (SMEs) Highlights: Issues 15 - 60

News bulletin for small and medium-sized enterprises - Issue 60

News bulletin for small and medium-sized enterprises - Issue 59

News bulletin for small and medium-sized enterprises - Issue 58

Reference Number: Issue 58

News bulletin for small and medium-sized enterprises - Issue 57

Reference Number: Issue 57

News bulletin for small and medium-sized enterprises - Issue 56

Reference Number: Issue 56

News bulletin for small and medium-sized enterprises - Issue 55

Reference Number: Issue 55

News bulletin for small and medium-sized enterprises - Issue 54

Reference Number: Issue 54

News bulletin for small and medium-sized enterprises - Issue 53

Reference Number: Issue 53

News bulletin for small and medium-sized enterprises - Issue 52

Reference Number: Issue 52

News bulletin for small and medium-sized enterprises - Issue 51

Reference Number: Issue 51Summary:

SME Newsletter - Issue 51

News bulletin for small and medium-sized enterprises - Issue 50

Reference Number: Issue 50

News bulletin for small and medium-sized enterprises - Issue 49

Reference Number: Issue 49

News bulletin for small and medium-sized enterprises - Issue 48

Reference Number: Issue 48

News bulletin for small and medium-sized enterprises - Issue 47

Reference Number: Issue 47

News bulletin for small and medium-sized enterprises - Issue 46

Reference Number: Issue 46

News bulletin for small and medium-sized enterprises - Issue 45

Reference Number: Issue 45

News bulletin for small and medium-sized enterprises - Issue 44

Reference Number: Issue 44Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 43

News bulletin for small and medium-sized enterprises - Issue 42

Reference Number: Issue 42

News bulletin for small and medium-sized enterprises - Issue 41

News bulletin for small and medium-sized enterprises - Issue 40

News bulletin for small and medium-sized enterprises - Issue 39

Reference Number: Issue 39Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 38

News bulletin for small and medium-sized enterprises - Issue 37

Reference Number: Issue 37Summary:

Information for SMEs on the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 36

Reference Number: Issue 36

News bulletin for small and medium-sized enterprises - Issue 35

News bulletin for small and medium-sized enterprises - Issue 34

Reference Number: Issue 34Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 33

Reference Number: Issue 33Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 32

Reference Number: Issue 32Summary:

Information for SMEs in the EU regulatory environment for medicines. Published four times a year by the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 31

Reference Number: Issue 31

News bulletin for small and medium-sized enterprises - Issue 30

Reference Number: Issue 30Summary:

A reflection paper on the requirements for the selection and justification of starting materials in the manufacture of chemical active substances has been adopted.

News bulletin for small and medium-sized enterprises - Issue 29

Reference Number: Issue 29Summary:

Annex 6 to ICH guideline Q4B “Evaluation and Recommendation of pharmacopoeial texts for use in the ICH Regions” came into effect in June 2014.

News bulletin for small and medium-sized enterprises - Issue 28

Reference Number: Issue 28Summary:

A guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products will come into effect on 1 September 2014 (EMA/CHMP/BWP/85290/2012).

News bulletin for small and medium-sized enterprises - Issue 27

Reference Number: Issue 27Summary:

A joint CHMP/CVMP guideline on process validation for finished products will come into effect on 15 June 2014 (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1).

News bulletin for small and medium-sized enterprises - Issue 26

Reference Number: Issue 26

News bulletin for small and medium-sized enterprises - Issue 25

Reference Number: Issue 25

News bulletin for small and medium-sized enterprises - Issue 24

News bulletin for small and medium-sized enterprises - Issue 23

News bulletin for small and medium-sized enterprises - Issue 22

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

News bulletin for small and medium-sized enterprises - Issue 21

News bulletin for small and medium-sized enterprises - Issue 20

Reference Number: Issue 20Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

News bulletin for small and medium-sized enterprises - Issue 19

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities

related to the European regulatory environment.

News bulletin for small and medium-sized enterprises - Issue 18

Summary:

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, ocuments and activities related to the European regulatory environment.

News bulletin for small and medium-sized enterprises - Issue 17

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency. The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

News bulletin for small and medium-sized enterprises - Issue 16

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

News bulletin for small and medium-sized enterprises - Issue 15

Summary:

This news bulletin is published four times a year by the SME Office of the European Medicines Agency.

The news bulletin aims to bring to the attention of SMEs, and their stakeholders, documents and activities related to the European regulatory environment.

Clinical Trials Highlights

Issues from July 2023 (Issue 15) onwards are available at the link below: 

• Clinical Trials Highlights: Issue 15 onwards

Use this link to receive Clinical Trials Highlights by email:

• Subscribe to Clinical Trials Highlights

Select the expandable panel below to access previous issues:

Clinical Trials Highlights: Issues 1 - 14

Clinical Trials Highlights - April 2023

Reference Number: Issue 14

Clinical Trials Highlights - February 2023

Reference Number: Issue 13

Clinical Trials Highlights - December 2022

Reference Number: Issue 12

Clinical Trials Highlights - October 2022

Reference Number: Issue 11

Clinical Trials Highlights - July 2022

Reference Number: Issue 10

Clinical Trials Highlights - May 2022

Reference Number: Issue 9

Clinical Trials Highlights - March 2022

Reference Number: Issue 8

Clinical Trials Information System (CTIS) highlights - January 2022

Reference Number: Issue 7

Clinical Trials Information System (CTIS) highlights - December 2021

Reference Number: Issue 6

Clinical Trials Information System (CTIS) highlights - October 2021

Reference Number: Issue 5

Clinical Trials Information System (CTIS) highlights - August 2021

Reference Number: Issue 4

Clinical Trials Information System (CTIS) highlights - June 2021

Reference Number: Issue 3

Clinical Trials Information System (CTIS) highlights - December 2020

Reference Number: Issue 2

 

Clinical Trials Information System (CTIS) highlights - June 2020

Reference Number: Issue 1

Veterinary Medicines Highlights

Issues from September 2023 (Issue 13) onwards are available at the link below: 

• Veterinary Medicines Highlights: Issue 13 onwards

Use this link to receive Veterinary Medicines Highlights by email: 

• Subscribe to Veterinary Medicines Highlights

Select the expandable panel below to access previous issues:

Veterinary Medicines Highlights: Issues 1 - 12

Veterinary Medicines Highlights - Issue 12

Reference Number: Issue 12

Veterinary Medicinal Products Regulation highlights - Issue 11

Reference Number: Issue 11

Veterinary Medicinal Products Regulation highlights - Issue 10

Reference Number: Issue 10

Veterinary Medicinal Products Regulation highlights - Issue 9

Reference Number: Issue 9

Veterinary Medicinal Products Regulation highlights - Issue 8

Reference Number: Issue 8

Veterinary Medicinal Products Regulation highlights - Issue 7

Reference Number: Issue 7

Veterinary Medicinal Products Regulation highlights - Issue 6

Reference Number: Issue 6Summary:

News, views and interviews for the Veterinary Medicinal Products Regulation. Published every two months by the European Medicines Agency

Veterinary Medicinal Products Regulation highlights - Issue 5

Reference Number: Issue 5

Veterinary Medicinal Products Regulation highlights - Issue 4

Reference Number: Issue 4

Veterinary Medicinal Products Regulation highlights - Issue 3

Reference Number: Issue 3

Veterinary Medicines Regulation highlights - Issue 2

Reference Number: Issue 2

Veterinary Medicines Regulation highlights - Issue 1

Reference Number: Issue 1Summary:

News, views and interviews for the Veterinary Medicines Regulation. Published four times a year by the European Medicines Agency.

Big Data Highlights

Issues from June 2023 (Issue 6) onwards are available at the link below: 

• Big Data Highlights: Issue 6 onwards

Use this link to receive Big Data Highlights by email: 

• Subscribe to Big Data Highlights

Select the expandable panel below to access previous issues from 2022: 

Big Data Highlights: Issues 1 - 5

Big Data highlights - Issue 1

Reference Number: Issue 1

Big Data highlights - Issue 2

Reference Number: Issue 2

Big Data highlights - Issue 3

Reference Number: Issue 3

 

Big Data highlights - Issue 4

Reference Number: Issue 4

Big Data highlights - Issue 5

Reference Number: Issue 5

 

Product Lifecycle Management Insights

Product Lifecycle Management Insights is available at the link below:

• Product Lifecycle Management Insights

Use this link to receive Product Lifecycle Management Insights by email:

• Subscribe to Product Lifecycle Management Insights

Clinical Trials Information System (CTIS) newsflash (discontinued)

EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.

From July 2025, the CTIS newsflash is replaced by Clinical Trials Highlights Newsletter.

CTIS newsflash – 24 June 2025

Reference Number: EMA/198062/2025

Select the expandable panel below to access issues published between 2022 and 2025:

Clinical Trials Information System (CTIS) newsflash: previous issues

CTIS newsflash - 10 June 2025

Reference Number: EMA/179146/2025

CTIS newsflash - 27 May 2025

Reference Number: EMA/175583/2025

CTIS newsflash - 16 May 2025

CTIS newsflash - 29 April 2025

Reference Number: EMA/124649/2025

CTIS newsflash - 25 March 2025

Reference Number: EMA/90566/2025

CTIS newsflash - 11 March 2025

Reference Number: EMA/72075/2025

CTIS newsflash - 25 February 2025

Reference Number: EMA/36861/2025

CTIS newsflash – 11 February 2025

Reference Number: EMA/37270/2025

CTIS newsflash – 28 January 2025

Reference Number: EMA/7145/2025

CTIS newsflash - 14 January 2025

Reference Number: EMA/582910/2024

CTIS newsflash - 17 December 2024

Reference Number: EMA/559561/2024

CTIS newsflash - 3 December 2024

Reference Number: EMA/541301/2024

CTIS newsflash - 19 November 2024

Reference Number: EMA/514303/2024

CTIS newsflash - 5 November 2024

Reference Number: EMA/501426/2024

CTIS newsflash - 22 October 2024

Reference Number: EMA/469994/2024

CTIS newsflash - 8 October 2024

Reference Number: EMA/441928/2024

CTIS newsflash - 24 September 2024

Reference Number: EMA/421508/2024

CTIS newsflash - 10 September 2024

Reference Number: EMA/374537/2024

CTIS newsflash - 9 August 2024

Reference Number: EMA/325160/2024

CTIS newsflash - 26 July 2024

Reference Number: EMA/334159/2024

CTIS newsflash - 12 July 2024

Reference Number: EMA/303545/2024

CTIS newsflash - 28 June 2024

Reference Number: EMA/291916/2024

CTIS newsflash – 14 June 2024

Reference Number: EMA/264069/2024

CTIS newsflash - 31 May 2024

Reference Number: EMA/240597/2024

CTIS newsflash - 17 May 2024

Reference Number: EMA/162262/2024

CTIS newsflash – 3 May 2024

Reference Number: EMA/174397/2024

CTIS newsflash - 22 April 2024

Reference Number: EMA/147229/2024

CTIS newsflash - 5 April 2024

Reference Number: EMA/128274/2024

CTIS newsflash - 22 March 2024

Reference Number: EMA/106948/2024

CTIS newsflash - 8 March 2024

Reference Number: EMA/84206/2024

CTIS newsflash - 23 february 2024

Reference Number: EMA/62843/2024

CTIS newsflash - 9 February 2024

Reference Number: EMA/43654/2024

CTIS newsflash - 26 January 2024

Reference Number: EMA/20807/2024

CTIS newsflash – 12 January 2024

Reference Number: EMA/586501/2023

CTIS newsflash – 22 December 2023

Reference Number: EMA/564292/2023

CTIS newsflash - 8 December 2023

Reference Number: EMA/536032/2023

CTIS newsflash – 24 November 2023

CTIS newsflash – 10 November 2023

Reference Number: EMA/486111/2023

CTIS newsflash – 27 October 2023

Reference Number: EMA/471461/2023

CTIS newsflash – 13 October 2023

Reference Number: EMA/440825/2023

CTIS newsflash - 29 September 2023

Reference Number: EMA/416454/2023

CTIS newsflash - 15 September 2023

Reference Number: EMA/397022/2023

CTIS newsflash - 1 September 2023

Reference Number: EMA/376569/2023

CTIS newsflash – 18 August 2023

Reference Number: EMA/356297/2023

CTIS newsflash - 4 August 2023

Reference Number: EMA/339073/2023

CTIS newsflash - 21 July 2023

Reference Number: EMA/293653/2023

CTIS newsflash - 7 July 2023

Reference Number: EMA/293590/2023

CTIS newsflash – 23 June 2023

CTIS newsflash - 9 June 2023

Reference Number: EMA/231823/2023

CTIS newsflash - 26 May 2023

Reference Number: EMA/220482/2023

CTIS newsflash - 12 May 2023

Reference Number: EMA/209485/2023

CTIS newsflash - 5 May 2023

Reference Number: EMA/186032/2023

CTIS newsflash - 28 April 2023

Reference Number: EMA/184144/2023

CTIS newsflash - 21 April 2023

Reference Number: EMA/171343/2023

CTIS newsflash - 14 April 2023

Reference Number: EMA/155249/2023

CTIS newsflash – 31 March 2023

Reference Number: EMA/141792/2023

CTIS newsflash – 24 March 2023

Reference Number: EMA/127714/2023

CTIS newsflash – 17 March 2023

Reference Number: EMA/114900/2023

CTIS newsflash - 10 March 2023

Reference Number: EMA/103161/2023

CTIS newsflash - 3 March 2023

Reference Number: EMA/89888/2023

CTIS newsflash - 24 February 2023

Reference Number: EMA/78479/2023

CTIS newsflash - 17 February 2023

Reference Number: EMA/69125/2023

CTIS newsflash - 10 February 2023

Reference Number: EMA/58602/2023

CTIS newsflash - 3 February 2023

Reference Number: EMA/47266/2023

CTIS newsflash - 27 January 2023

Reference Number: EMA/36776/2023

CTIS newsflash – 20 January 2023

Reference Number: EMA/23426/2023

CTIS newsflash – 13 January 2023

Reference Number: EMA/6441/2023

CTIS newsflash - 6 January 2023

Reference Number: EMA/957698/2022

CTIS newsflash - 22 December 2022

Reference Number: EMA/940077/2022

CTIS newsflash - 12 December 2022

CTIS newsflash - 5 December 2022

CTIS newsflash - 22 April 2022

CTIS newsflash - 8 April 2022

CTIS newsflash - 1 April 2022

Reference Number: EMA/193739/2022

CTIS newsflash - 25 March 2022

Reference Number: EMA/183329/2022

CTIS newsflash - 18 March 2022

Reference Number: EMA/168795/2022

CTIS newsflash - 11 March 2022

Reference Number: EMA/149078/2022

CTIS newsflash - 4 March 2022

Reference Number: EMA/131960/2022

CTIS newsflash - 25 February 2022

Reference Number: EMA/119802/2022

CTIS newsflash - 18 February 2022

Reference Number: EMA/104967/2022

CTIS newsflash - 11 February 2022

Reference Number: EMA/83300/2022

CTIS newsflash - 4 February 2022

Reference Number: EMA/70002/2022

Pharmacovigilance newsletter (discontinued)

'What's new in pharmacovigilance'provided regular updates on guidance, regulations and events. EMA has replaced this newsletter with targeted communications to qualified persons for pharmacovigilance (QPPV) as needed.

Select the expandable panel below to access all issues published between 2014 and 2019:

Pharmacovigilance newsletter: all issues

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019

Reference Number: Issue 1 - 2019

What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018

Reference Number: Issue 2

What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2018

Reference Number: Issue 1Summary:

This qualified persons responsible for pharmacovigilance (QPPV) update provides QPPVs and all other people working in pharmacovigilance with an

update on European Union (EU) pharmacovigilance, relating to

medicines for human use.

What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017

Reference Number: Issue 3 - 2017

What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017

What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017

Reference Number: Issue 1 - 2017

What's new in pharmacovigilance - QPPV Update - Issue 3

Reference Number: Issue 3

What's new in pharmacovigilance - QPPV Update - Issue 2

Reference Number: Issue 2

What's new in pharmacovigilance - QPPV Update - Issue 1

Reference Number: Issue 1

News bulletin for pharmacovigilance programme update - Issue 6

Reference Number: Issue 6Summary:

News bulletin for pharmacovigilance programme update

News bulletin for pharmacovigilance programme update - Issue 5

Reference Number: Issue 5

News bulletin for pharmacovigilance programme update - Issue 4

Reference Number: Issue 4

News bulletin for pharmacovigilance programme update - Issue 3

Reference Number: Issue 3

News bulletin for pharmacovigilance programme update - Issue 2

Reference Number: Issue 2Summary:

This second Pharmacovigilance Programme Update is primarily aimed at providing marketing authorisation holders (MAHs) with information to help prepare for the business change to come.

News bulletin for pharmacovigilance programme update - Issue 1

Reference Number: Issue 1Summary:

This Update is the first in a series of documents primarily aimed at providing marketingauthorisation holders (MAHs) with information on the development of the enhanced systems, helping MAHs prepare for the business change to

come.

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter (discontinued)

EMA discontinued the electronic Application Form (eAF) - Product Management Service (PMS) newsletter in 2023.

News on the eAF and PMS products can be found in the newsletter Product Lifecycle Management Insights.

For more information on PLM and PMS, please see:

• PLM Portal
• eSubmissions: PLM Portal eAF (DADI)
• Substance and product data management services

Select the expandable panel below to access the issues published between 2022 and 2023:

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter: Issues 1 - 3

Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3

Reference Number: Issue 3

 

Electronic Application Form (eAF) newsletter - Issue 2

Reference Number: Issue 2

 

Digital Application Dataset Integration (DADI) newsletter - Issue 1

Reference Number: Issue 1